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In this section: Enforcement Activities | FDA

FDA notification regarding unapproved drugs included in kits

Stop distributing unapproved drugs included in kits

On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as "Unit-of-Use Prescription Compounding Kits," including:

FIRST Lansoprazole
FIRST Pantoprazole
FIRST Metronidazole
FIRST Mouthwash BLM

These kits have not been proven safe and effective and do not qualify for exemptions under the compounding provisions in sections 503A and 503B of the Federal Food, Drug and Cosmetic Act.

FDA encourages companies marketing unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drug marketed in the United States.

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